The present invention relates generally to medical products and compositions for making same. More specifically, the present invention relates to non-PVC material and medical tubing made therefrom.
It is known to use closures for blood containers and IV containers that consist of membrane tubes. In this regard, once a drug container is filled through an open-ended filling port, a membrane tube closure is coated with a solvent, such as cyclohexanone, and inserted into a fill port tubing. During this process, a chemical bond is achieved between the fill port and the membrane tube closure. When it is desired to access the container, an end user pierces the membrane, in the tube, to allow drug administration or other access to the container.
Typically, such a medical membrane tubing is constructed from plasticized polyvinyl chloride (PVC). Usually, the PVC is plasticized with DEHP.
Recently, there has been concern with respect to the use of DEHP plasticized PVC. DEHP has been alleged to be a suspected carcinogen. However, the characteristics that are afforded by plasticized PVC are very desirable especially in the medical area and for uses such as in a membrane tube closure for a container.
In this regard, such medical tubings should exhibit certain characteristics. It is desirable that the tubing can be solvent bonded to a PVC container as well as containers constructed from other alloys. It is also desirable that the tubing is RF sealable to formi membrane tube closures so as to be usable with current manufacturing equipment.
Additionally, the materials should be autoclavable without cross-linking at 121.degree. C. Further, it would be desirable if the tubing was compatible with currently used manufacturing machines. Moreover, the material should be sterilizable via either ETO or gamma sterilization processes. Likewise, in order to be a usable membrane tube closure, the material must be easy to pierce during drug administration and allow the spike to be removed after the drug is administered. Additionally, it is desirable that the scrap is recyclable for further use.
Although there are other components in the art from which, arguably, medical tubing could be created, each of these components suffers disadvantages. Most importantly, the resultant product does not have the same desirable characteristics as a plasticized PVC product.
For example, flexible polyester is not as RF responsive as is plasticized PVC. Aliphatic polyurethane is not autoclavable. Further, such tubings, due to their characteristics, cannot be used on currently available commercial machinery in, for example, a blood collection system.
U.S. patent application Ser. No. 07/270,006, filed Nov. 14, 1988 now U.S. Pat. No. 5,026,347, discloses a citrate ester and a non-PVC material. U.S. patent application Ser. No. 07/494,045, filed May 15, 1990, now U.S. Pat. No. 5,100,401, is a divisional application to that patent application. Both of these applications are assigned to the assignee of the present invention.
U.S. patent application Ser. No. 07/636,337, filed Dec. 31, 1990, now abandoned, and assigned to the assignee of the present invention, relates to a medical grade tubing comprising a blend of polyurethane and polyester, and the resultant tubing being autoclavable and RF sealable. A continuation-in-part to that patent application, U.S. Ser. No. 07/828,436, now U.S. Pat. No. 5,533,992 is being filed on the same day as this patent application.